Adding Cognitive Behavioral Therapy to Drug Treatment for Social Anxiety Disorder

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Temple University
ClinicalTrials.gov Identifier:
NCT00074802
First received: December 19, 2003
Last updated: March 5, 2014
Last verified: September 2008
  Purpose

This study will determine whether the addition of cognitive behavioral therapy can improve the effectiveness of the medication paroxetine (Paxil®) in treating individuals with social anxiety disorder.


Condition Intervention Phase
Social Anxiety Disorder
Drug: Paroxetine
Behavioral: Cognitive behavioral therapy (CBT)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CBT Augmentation of Paroxetine for Social Anxiety

Resource links provided by NLM:


Further study details as provided by Temple University:

Primary Outcome Measures:
  • Liebowitz Social Anxiety Scale [ Time Frame: Measured at baseline and Weeks 12, 28, and 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Social Interaction Anxiety Scale [ Time Frame: Measured at baseline and Weeks 12, 28, and 52 ] [ Designated as safety issue: No ]
  • Sheehan Disability Scale [ Time Frame: Measured at baseline and Weeks 12, 28, and 52 ] [ Designated as safety issue: No ]
  • Quality of Life Inventory [ Time Frame: Measured at baseline and Weeks 12, 28, and 52 ] [ Designated as safety issue: No ]
  • Clinical Global Impression Improvement Scale [ Time Frame: Measured at baseline and Weeks 12, 28, and 52 ] [ Designated as safety issue: No ]

Enrollment: 153
Study Start Date: December 2003
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive treatment with paroxetine
Drug: Paroxetine
Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.
Other Name: Paxil
Experimental: 2
Participants will receive treatment with paroxetine plus cognitive behavioral therapy
Drug: Paroxetine
Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.
Other Name: Paxil
Behavioral: Cognitive behavioral therapy (CBT)
CBT will consist of 16 weekly treatment sessions.

Detailed Description:

Social anxiety disorder is a prevalent and disabling condition for which effective long-term treatments need to be identified. Paroxetine is effective in treating the acute symptoms of social anxiety, but longer-term management remains a challenge. Cognitive behavioral therapy (CBT) has been effective in treating depression and panic disorder symptoms; it may also be effective in augmenting paroxetine response and reducing relapse after medication discontinuation. This study will examine the effects of paroxetine treatment alone and in combination with CBT.

Participants in this study will receive paroxetine for 12 weeks. After 12 weeks, participants will be randomly assigned to either add weekly sessions of CBT to their treatment or to continue taking paroxetine alone for another 16 weeks. After the 16-week treatment period, participants will have their treatments tapered and will be followed for an additional 24 weeks. Social anxiety symptoms, rates of remission, and quality of life will be assessed.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • DSM-IV criteria for generalized social phobia
  • Willing and able to give written informed consent
  • English-speaking

Exclusion Criteria:

  • Prior or current diagnosis of schizophrenia, schizoaffective disorder, organic mental disorder, bipolar disorder, or antisocial, schizotypal, and schizoid personality disorders
  • Suicidal thoughts
  • History of failed paroxetine treatment of at least 6 weeks' duration at adequate doses or a history of failed outcome of a previous adequate trial of CBT
  • Clinically significant and/or unstable medical disease
  • Pregnancy or breast-feeding. Women of childbearing potential will be required to sign a statement indicating their intention to avoid pregnancy during the study through the use of an effective method of contraception.
  • Alcohol or substance abuse or dependence within the past 3 months. Patients with a positive drug screen but no substance abuse disorder will be eligible for the study, provided they have not met criteria for abuse/dependence within the last 6 months and provide two clean urine samples 2 weeks apart.
  • Current or past history of seizure disorder (except febrile seizure in childhood)
  • Conditions that contraindicate the use of paroxetine
  • Inability to tolerate or unwillingness to accept a drug-free period of 4 weeks for monoamine oxidase inhibitors (MAOIs) or fluoxetine and 2 weeks for other selective serotonin reuptake inhibitors (SSRIs), neuroleptics, antidepressants, benzodiazepines, mood stabilizers, buspirone, beta-adrenergic blockers, or other psychotropic drugs prior to beginning the study
  • Currently receiving psychotherapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00074802

Locations
United States, New York
New York State Psychiatric Institute Anxiety Disorders Clinic
New York, New York, United States, 10032
United States, Pennsylvania
Adult Anxiety Clinic of Temple University
Philadelphia, Pennsylvania, United States, 19122-6085
Sponsors and Collaborators
Temple University
Investigators
Principal Investigator: Richard Heimberg, PhD Adult Anxiety Clinic of Temple University
Principal Investigator: Michael Liebowitz, MD New York State Psychiatric Institute Anxiety Disorders Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Richard Heimberg, Principal Investigator, Temple University
ClinicalTrials.gov Identifier: NCT00074802     History of Changes
Other Study ID Numbers: R01 MH64481, R01MH064481, DSIR 83-ATAS, R01 MH64726, GSK ID: 101618
Study First Received: December 19, 2003
Last Updated: March 5, 2014
Health Authority: United States: Federal Government

Keywords provided by Temple University:
Social Phobia

Additional relevant MeSH terms:
Anxiety Disorders
Disease
Phobic Disorders
Mental Disorders
Pathologic Processes
Paroxetine
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014